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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND ACCOLADE IMPLANTABLE PULSE GENERATOR

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GUIDANT CRM CLONMEL IRELAND ACCOLADE IMPLANTABLE PULSE GENERATOR Back to Search Results
Model Number U128
Device Problems Over-Sensing (1438); Pacing Problem (1439); Under-Sensing (1661)
Patient Problems No Consequences Or Impact To Patient (2199); Complete Heart Block (2627)
Event Date 06/12/2017
Event Type  Injury  
Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete. This investigation will be updated should further information be provided.
 
Event Description
Boston scientific received information that during a follow-up appointment, it was noted that this patient had multiple pacemaker mediated tachycardia episodes and one non-sustained ventricular tachycardia. The patient was given a holter monitor and upon review, it was noted this cardiac resynchronization therapy pacemaker (crt-p) exhibited undersensing of p-waves and crosstalk oversensing on the right ventricular (rv) channel. The oversensing resulted in pacing inhibition greater than 2. 5 seconds. The patient also has congenital heart block. The rv lead is a competitor's product. This crt-p was reprogrammed and remains in service. No additional adverse patient effects were reported.
 
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Brand NameACCOLADE
Type of DeviceIMPLANTABLE PULSE GENERATOR
Manufacturer (Section D)
GUIDANT CRM CLONMEL IRELAND
guidant ireland
clonmel, tipperary ireland
Manufacturer (Section G)
GUIDANT CRM CLONMEL IRELAND
guidant ireland
clonmel, tipperary ireland
Manufacturer Contact
tim degroot
4100 hamline ave. n
st. paul, MN 
6515826168
MDR Report Key6706656
MDR Text Key79808163
Report Number2124215-2017-11251
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 06/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/07/2019
Device Model NumberU128
Other Device ID NumberVALITUDE X4
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received06/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/07/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/12/2017 Patient Sequence Number: 1
Treatment
4266; 4524; 4674; 5826; MISMATCH; U128
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